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Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection

Primary Purpose

Ischemic Stroke

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

aspirin

warfarin

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Cervicocephalic Arterial Dissection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical and imaging diagnosis of cervicocephalic arterial dissection within 3 months. Exclusion Criteria: Any contraindication to aspirin or warfarin.

Sites / Locations

UCSD Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

aspirin

warfarin

Arm Description

Outcomes

Primary Outcome Measures

Incidence of stroke by one year.

Secondary Outcome Measures

Recurrent dissection by one year.

Incidence of TIA by one year.

Incidence of major and minor bleeding episodes by one year.

Full Information

NCT ID

NCT00265408

First Posted

December 12, 2005

Last Updated

December 5, 2014

Sponsor

University of California, San Diego

1. Study Identification

Unique Protocol Identification Number

NCT00265408

Brief Title

Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection

Official Title

Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection

Study Type

Interventional

2. Study Status

Record Verification Date

March 2007

Overall Recruitment Status

Withdrawn

Study Start Date

December 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University of California, San Diego

4. Oversight

5. Study Description

Brief Summary

Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection.

Detailed Description

20 patients with cervicocephalic arterial dissection will be randomized to open-label aspirin or warfarin, rate of stroke and adverse events will be endpoints.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

Keywords

Cervicocephalic Arterial Dissection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

aspirin

Arm Type

Experimental

Arm Title

warfarin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

aspirin

Intervention Type

Drug

Intervention Name(s)

warfarin

Primary Outcome Measure Information:

Title

Incidence of stroke by one year.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Recurrent dissection by one year.

Time Frame

1 year

Title

Incidence of TIA by one year.

Time Frame

1 year

Title

Incidence of major and minor bleeding episodes by one year.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical and imaging diagnosis of cervicocephalic arterial dissection within 3 months. Exclusion Criteria: Any contraindication to aspirin or warfarin.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matt B Jensen, MD

Organizational Affiliation

UCSD Stroke Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSD Medical Center

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection

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